FDLI Publications - Monograph Volume 1, Number 5

FDLI Monograph Series
Volume 1, Number 5

Selling Pharmaceuticals and Biologics to the Federal Government: Federal Supply Schedule
and Federal Pricing Requirements
Joy E. Sturm, Partner, Hogan Lovells US LLP
Allison D. Pugsley, Associate, Hogan Lovells US LLP
Stephen A. Smyers, Associate, Hogan Lovells US LLP

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Table of Contents, About the Authors, About this Monograph, Introduction and the first page of every chapter

About This Monograph

Does your company have a Federal Supply Schedule contract with the Department of Veterans Affairs?
Is your company marketing its first innovator product or its first authorized generic?
Is your company considering rolling out a new marketing program that would involve extending off-invoice discounts or rebates to wholesalers or other customers?

If you answered “yes” to any of these questions, FDLI’s newest monograph will provide you with essential information relating to the federal programs that impose government contracting requirements and price caps on your company’s products. This monograph clearly details how commercial pricing decisions can have a very significant impact on your company’s pricing in the federal marketplace—and, ultimately on its bottom line.

Any manufacturer that seeks to have federal funds made available to pay for its products under the Medicaid and Medicare Part B programs must agree to participate in the Federal Supply Schedule (FSS) and Veterans Health Care Act of 1992 (VHCA) contracting and pricing programs. Increased federal enforcement efforts surrounding these programs coupled with the recent extension of the VHCA federal pricing requirements to the Department of Defense’s nationwide TRICARE pharmacy program, have caused manufacturers—of all sizes—to place additional emphasis on their federal contracting and pricing functions.

This monograph is the first-ever publication summarizing the requirements under the
federal government’s pharmaceuticals and biologics contracting and related pricing programs,
which include:

The VA Federal Supply Schedule Contracting Program;
The Veterans Health Care Act of 1992 Section 603 Pricing Program; and
The Tricare Retail Pharmacy (TRRx) Rebate Program.

And, as an aid to readers, an extensive glossary is included.

Bottom Line: This monograph enables you to understand the mechanics of pricing calculations and federal contracting requirements, understand how common commercial pricing and discounting arrangements can impact (and, often reduce) the prices that a company must charge the government for its drugs and biologics, and enable the issue-spotting and strategic thinking necessary to minimize compliance risk and to maximize commercial outcomes.

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FDLI Monograph Series Volume 1, Number 5